Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes - A randomized clinical trial
Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes - A randomized clinical trial
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DOI：
10.2337/diacare.27.5.1081
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发表时间：
2004-05-01
期刊：
影响因子：
16.2
通讯作者：
Draeger, E
中科院分区：
文献类型：
--
作者：
Home, P;Bartley, P;Draeger, E
目的：胰岛素地替米尔是一种可溶的长效基础胰岛素类似物，旨在克服传统基础胰岛素制剂的局限性。因此，在血糖控制(糖化血红蛋白(1c)、早餐前血糖水平和变异性以及低血糖)和给药时机方面，地特胰岛素与NPH胰岛素进行了比较。研究设计与方法--1型糖尿病患者(n-408)被随机分为两组，分别使用地特胰岛素或NPH胰岛素进行为期16周的开放平行分组试验。每日两次使用两种不同的给药方案，早餐前和睡前(IDET(早+床))或间隔12小时(IDET(12小时))NPH胰岛素在早餐前和睡前给药。结果两组患者的临床空腹血糖均低于NPH胰岛素组(IDET(12h)vs NPH，-1.5mmo1/L[95%CI-2.51vs-0.48]，P=0.004；IDET(晨间+床)vs NPH，-2.3mmoL/L(-3.32vs-1.29)，P<；0.001)，IS是自测早餐前血糖(分别为P=0.006和P=0.004)。在治疗的最后12周内，两组地特胰岛素组发生轻微低血糖的风险(分别为25%，P=0.0461 32%，P=0.002)均低于NPH胰岛素组，这主要归因于IDET(Morn+Bed)组夜间低血糖降低了53%(P<；0.001)。尽管各胰岛素组的HbA(1c)与NPH组无差异，但合并胰岛素组的HbA(1c)显著低于NPH组(平均-0.18%[-0.34~-0.02]，P=0.027)。两组患者自测早餐前血糖的人内日内变化均较低(P<；0.001)。在研究过程中，NPH组体重增加，但两个胰岛素组的体重均无变化(IDET(12h)vs NPH，-0.006.8kg1.44至-0.2 4，P=0.0 5%IDET(晨间+床)vs NPH，-0.6 kg[-1.2 3至-0.0 3]，P=0.040)。这些数据为根据个人需要调整给药时间提供了依据。
OBJECTIVE-Insulin detemir is a soluble long-acting basal insulin analog designed to overcome the limitations of conventional basal insulin formulations. Accordingly, insulin detemir has been compared with NPH insulin with respect to glycemic control (HbA(lc), prebreakfast glucose levels and variability, and hypoglycemia) and timing of administration.RESEARCH DESIGN AND METHODS - People with type 1 diabetes (n - 408) were randomized in an open-label, parallel-group trial of 16-week treatment duration using either insulin detemir or NPH insulin. Insulin detemir was administered twice daily using two different regimens, either before breakfast and at bedtime (IDet(morn +bed)) or at a 12-h interval (IDet(12h)) NPH insulin was administered before breakfast and at bedtime. Mealtime insulin was given as rapid-acting insulin analog insulin aspart.RESULTS - With both insulin detemir groups, clinic fasting plasma glucose was lower than with NPH insulin (IDet(12h) vs. NPH, -1.5 mmol/l [95% Cl -2.51 to -0.48], P = 0.004; IDet(morn + bed) vs NPH, -2.3 mmol/l (-3.32 to -1.29), P < 0.001), is was self-measured prebreakfast plasma glucose (P = 0.006 and P = 0.004, respectively) The risk of minor hypo-glycemia was lower in both insulin detemir groups (25%, P = 0.0461 32%, P = 0.002, respeclively) compared with NPH insulin in the last 12 weeks of treatment, this being mainly attributable to a 53% reduction in nocturnal hypoglycemia in the IDet(morn+bed) group (P < 0.001). Although HbA(1c) for each insulin detemir group Was not different from the NPH group, HbA(1c) for the pooled insulin detemir groups was significantly lower than for the NPH group (mean difference -0.18% [-0.34 to -0.02], P = 0.027). Within-person between-day variation in self-measured prebreakfast plasma glucose was lower for both detemir groups (both P < 0.001). The NPH group gained weight during the study, but there was no change in weight in either of the insulin detemir groups (IDet(12h) vs. NPH, -0.8 kg \ -1.44 to -0.24], P = 0.006 IDet(morn + bed) vs NPH, -0.6 kg [- 1.23 to -0.03], P = 0.040).CONCLUSIONS - Overall glycemic control with insulin detemir was improved compare with NPH insulin. The data provide a basis for tailoring the timing of administration of insulin detemir to the individual person's needs.